Randomized, double-blind, pilot evaluation of intravenous glutathione in Parkinson's disease.
Identifieur interne : 001C06 ( PubMed/Checkpoint ); précédent : 001C05; suivant : 001C07Randomized, double-blind, pilot evaluation of intravenous glutathione in Parkinson's disease.
Auteurs : Robert A. Hauser [États-Unis] ; Kelly E. Lyons ; Terry Mcclain ; Summer Carter ; David PerlmutterSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2009.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Double-Blind Method, Drug Evaluation, Female, Glutathione (therapeutic use), Humans, Injections, Intravenous (methods), Male, Mental Status Schedule, Middle Aged, Parkinson Disease (drug therapy), Pilot Projects, Severity of Illness Index, Time Factors.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Glutathione.
- drug therapy : Parkinson Disease.
- methods : Injections, Intravenous.
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Drug Evaluation, Female, Humans, Male, Mental Status Schedule, Middle Aged, Pilot Projects, Severity of Illness Index, Time Factors.
Abstract
The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo-controlled, double-blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty-one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study.
DOI: 10.1002/mds.22401
PubMed: 19230029
Affiliations:
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pubmed:19230029Le document en format XML
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<author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Neurology, University of South Florida, Tampa, Florida 33606, USA. rhauser@health.usf.edu</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of South Florida, Tampa, Florida 33606</wicri:regionArea>
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<author><name sortKey="Lyons, Kelly E" sort="Lyons, Kelly E" uniqKey="Lyons K" first="Kelly E" last="Lyons">Kelly E. Lyons</name>
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<author><name sortKey="Mcclain, Terry" sort="Mcclain, Terry" uniqKey="Mcclain T" first="Terry" last="Mcclain">Terry Mcclain</name>
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<author><name sortKey="Carter, Summer" sort="Carter, Summer" uniqKey="Carter S" first="Summer" last="Carter">Summer Carter</name>
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<author><name sortKey="Perlmutter, David" sort="Perlmutter, David" uniqKey="Perlmutter D" first="David" last="Perlmutter">David Perlmutter</name>
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<term>Double-Blind Method</term>
<term>Drug Evaluation</term>
<term>Female</term>
<term>Glutathione (therapeutic use)</term>
<term>Humans</term>
<term>Injections, Intravenous (methods)</term>
<term>Male</term>
<term>Mental Status Schedule</term>
<term>Middle Aged</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Pilot Projects</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
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<term>Humans</term>
<term>Male</term>
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<front><div type="abstract" xml:lang="en">The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo-controlled, double-blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty-one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study.</div>
</front>
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<Month>06</Month>
<Day>03</Day>
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<DateCompleted><Year>2009</Year>
<Month>08</Month>
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<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
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<Abstract><AbstractText>The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo-controlled, double-blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty-one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study.</AbstractText>
<CopyrightInformation>(c) 2009 Movement Disorder Society.</CopyrightInformation>
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<CommentsCorrections RefType="CommentIn"><RefSource>Mov Disord. 2010 May 15;25(7):961-2; author reply 962-3</RefSource>
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